Study Using WST11 in Patients With Non-Resectable or Inoperable Cholangiocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Evaluation of the safety based on analysis of adverse events , clinical laboratory tests, electrocardiogram, physical examination, absence of local or general complications and phototoxicity of WST11 in inoperable or non resectable cholangiocarcinoma [ Time Frame: Patient inclusion - Month 6 ]

Evaluation of the safety based on analysis of adverse events (clinical laboratory tests, electrocardiogram, physical examination, absence of local or general complications and phototoxicity) of WST11 in inoperable or non resectable cholangiocarcinoma [ Time Frame: Patient inclusion - Month 6 ]

Evaluation of the effect of WST11-mediated VTP therapy on cholestasis and on the incidence of biliary complications of obstructive origin. [ Time Frame: Month 1, Month 3 & Month 6 ]

Evaluation of the effect of treatment on patient quality of life QLQ-C30. [ Time Frame: Month 1, Month 3 & Month 6 ]

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Study Using WST11 in Patients With Non-Resectable or Inoperable Cholangiocarcinoma

Official Title ICMJE

Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy in Non-resectable or Inoperable Cholangiocarcinoma

Brief Summary

The aim of this study is to evaluate the safety of Vascular Targeted Photodynamic therapy with WST11 in patients with non-resectable or inoperable biliary carcinoma.

Detailed Description

This is an open-label, prospective, multicentre, phase IIa study, evaluating a new therapeutic agent in the management of patients suffering from inoperable or non resectable biliary carcinoma. The patients will receive the dose of WST11 according to order of inclusion. The first 3 patients will receive 2.5 mg/kg. In the absence of toxicity, the following 9 patients will receive the dose of 5 mg/kg.

The patient is to receive anesthesia. WST11-mediated therapy will consist of the combination of single IV administration of WST11 at doses of 2.5mg/kg or 5mg/kg, using 753nm laser light at a fixed power of (150mW/cm) and light energy (200 J/cm) delivered through a diffusing fiber. The fiber is introduced in a transparent standard ERCP catheter and positioned under radioscopy in front of the lesion.

WST11-mediated VTP will consist of the combination of a single IV administration of WST11 at doses of 2.5 and 5 mg/kg, using 753nm laser light at a fixed power (150 mW/cm) and light energy (200 J/cm). Illumination in the bile duct is performed by inserting a diffusing fiber, with cylindrical uniform light distribution, in a transparent standard ERCP catheter and by positioning, under radioscopy, the illumination tip of the diffusing fiber in front of the lesion.

Other Name: WST11-mediated VTP

Study Arms

Experimental: WST11

Treatment with WST11-mediated VTP

Intervention: Drug: WST11

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Terminated

Enrollment ICMJE

8

Completion Date

September 2012

Primary Completion Date

June 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Patient having signed the consent form to take part in the study

Patient aged over 18 years, with no upper age limit

Patient with histologically proven cholangiocarcinoma

Patient with cholangiocarcinoma, inoperable or non resectable owing to extension, age or concomitant diseases

Bilirubin level decrease of more than 50% after stent insertion compared to base level

Patient with a WHO Performance Scale ≤ 2

Patient in whom efficient drainage is performed by means of a plastic biliary stent endoscopically or radiologically

Patient capable of completing the quality of life questionnaires

Women of child-bearing potential must have a negative pregnancy test, and must thereafter prove to be using acceptable contraception (oral contraceptive pill, hormone patches, or IUD)